MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETI

Catalog Number ASA-25090-SBS

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the introducer needles are very flimsy, and the needle bent badly when it hit bone.There was concern that it would break.

Event Description

It was reported that the introducer needles are very flimsy, and the needle bent badly when it hit bone.There was concern that it would break.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.Teleflex will a device history record review was performed with no relevant findings.Visual inspection could not be performed as no sample was returned for analysis.However, the customer did provide a photo that appears to show a needle's bent cannula.However, based on the returned photo, it appears to be an injection needle and not an introducer needle as described in the complaint description.A review of design change history for kit asa-25090-sbs and part numbers n-25090-002, k-09903-032, and k-04020-009 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.Complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of a needle bending during use was confirmed based on a photo provided from the customer.Visual examination of the customer's provided photo appears to show a bent cannula for an injection needle and not an introducer needle as described in the complaint description.A device history record review was performed with no evidence to suggest a manufacturing related cause.Therefore, based on the photo provided, operational context caused or contributed to this event.

• Brand Name: SPINAL ANESTHESIA KIT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETI
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8041346
• MDR Text Key: 126371354
• Report Number: 3006425876-2018-00699
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: ASA-25090-SBS
• Device Lot Number: 23F18J0234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1